Cannabis Gummy for the Improvement of Sleep and Quality of Life in Patients With Cancer, Pillow Trial

Summary

This clinical trial tests how well a cannabis gummy works in improving sleep and quality of life in patients with cancer. Many people with cancer (about 60%) have trouble sleeping, which can lower their quality of life. Sleep disturbance is defined as difficulty initiating or maintaining sleep, waking up earlier than desired and being unable to fall back to sleep, and excessive daytime sleepiness. In adults with cancer, sleep disturbance may be caused by multiple, often co-occurring factors including diagnosis, type, and stage of cancer, treatment regimen, physical complaints (e.g., pain), and psychological distress. Some patients use cannabis to help with sleep, but its effects are not well understood. Cannabis, which some people call marijuana, refers to the dried leaves, flowers, stems, and seeds of the cannabis sativa L plant. The plant contains at least 125 different cannabinoids, including delta-9 tetrahydrocannabinol (THC). Delta-9 THC is the most abundant form of THC in the cannabis plant. It has intoxicating effects, meaning it can temporarily alter a person's mood, thoughts, and perceptions (a "high"). This study will help researchers learn how cannabis affects sleep and quality of life compared to usual care.

Conditions

• Hematopoietic and Lymphatic System Neoplasm
• Malignant Solid Neoplasm

Interventions

OTHER

Actigraphy

Ancillary studies

OTHER

Best Practice

Receive usual care

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

OTHER

Ecological Momentary Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Single Agent Therapy

Given cannabis gummy PO

Sponsors & Collaborators

• Theodore Brasky PhD

  lead OTHER

Principal Investigators

• Theodore Brasky, PhD · Ohio State University Comprehensive Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-01

Primary Completion

2027-07-31

Completion

2027-12-31

FDA Drug

Yes

Countries

• United States

Study Locations